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Clinical Trial Record

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QYHJ Granules Versus Xeloda in Metastatic Pancreatic Cancer

2013-01

2015-08

2015-12

60

Study Overview

QYHJ Granules Versus Xeloda in Metastatic Pancreatic Cancer

Primary End Point: - To compare the overall survival (OS) using QYHJ Granules or Xeloda as the second therapy in patients with metastatic pancreatic cancer. Secondary End Points: * Compare clinical efficacy by other measures including PFS,tumor response,and changes in quality of life (QOL) between these two groups. * Examine the feasibility and assess the side effects of treatment using QYHJ Granules in patients with metastatic pancreatic cancer.

N/A

  • Metastatic Pancreatic Cancer
  • DRUG: Xeloda
  • DRUG: QYHJ Granules
  • TCM-002

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2012-12-16  

N/A  

2013-02-20  

2013-02-20  

N/A  

2013-02-22  

2013-02-22  

N/A  

2013-02  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/ArmIntervention/Treatment
ACTIVE_COMPARATOR: Xeloda

Subjects will receive Xeloda until progression

DRUG: Xeloda

  • Xeloda dose is calculated according to body surface area.The recommended dose is 1000 mg/m² administered orally twice daily (morning and evening; equivalent to 2000 mg/m² total daily dose) for 2 weeks followed by a 1-week rest period given as 3-week cycle
EXPERIMENTAL: QYHJ Granules

patients will receive QYHJ Granules until progression

DRUG: QYHJ Granules

  • 1-4 bags bid , days 1-42, every 6 weeks
Primary Outcome MeasuresMeasure DescriptionTime Frame
overall survival (OS)up to 3 years
Secondary Outcome MeasuresMeasure DescriptionTime Frame
Progression free survival（PFS）up to 3 years
Tumor response（ORR、DCR）up to 3 years
Clinical benefit rate （CBR）and QOL assessmentup to 3 years
Number of adverse events of QYHJ Formulaup to 3 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    Inclusion Criteria:

  • Histologically/cytologically confirmed metastatic pancreatic adenocarcinoma.
  • Patients have failed from the prior chemotherapy without Xeloda. Adjuvant chemotherapy containing Xeloda and 6 months before recruitment is included.
  • Patients haven't taken QYHJ Granules before. Prior exposure to Traditional Chinese Medicine not based on QYHJ Formula is allowed provided that at least one week washout time is given prior to initiation of experimental treatment.
  • ECOG performance status 0, 1 or 2.
  • Measurable disease by RECIST criteria must be present. Bone scan abnormalities alone will not be accepted as measurable disease. Lytic lesions seen on plain radiographs will not be accepted as measurable disease but will be evaluated in conjunction with bone scan abnormalities. Pure blastic bone metastases will not be accepted as measurable disease. Pleural or peritoneal effusions will not be accepted as measurable disease. Irradiated lesions are not considered measurable.
  • Patients must not be pregnant. Serum beta-HCG will be checked in all premenopausal patients.
  • Patients must have adequate organ functions reflected by the laboratory criteria below: neutrophil counts ≥ 1.5×109 /L, platelet count ≥ 100 x 109/L, hemoglobin ≥ 85 g/L, Serum creatinine < 2.0 mg/dL, Bilirubin < 1.5 mg/dL, ALT < 3 x normal, albumin >30g/L.
  • Age ≥ 18.
  • Prior local therapy, e.g., TACE or radiation, is allowed provided that at least 4 weeks washout time is given.
  • Concomitant bisphosphonates are allowed for patients with bone metastases. Patients with jaundice must have a biliary drainage decompression operation before recruitment.
  • Ability to understand and the willingness to sign a written informed consent.
  • Subjects who have a life expectancy of at least 3 months.

    • Exclusion Criteria:

  • ECOG performance status 3 or 4.
  • Known central nervous system involvement and leptomeningeal disease.
  • Previous Xeloda-based chemotherapy （except usage for Adjuvant chemotherapy and 6 months before recruitment）.
  • Prior treatment with QYHJ Granules.
  • Other serious illness or condition including cardiac disease including congestive heart failure (New York Heart Association Classification III or IV),unstable angina, myocardial infarction within the past six months, severe arrhythmia.
  • Concurrent infection requiring intravenous antibiotics, active HIV infection/HIV disease, psychiatric disorders, drug abuse.
  • Known allergies to the QYHJ or Xeloda.
  • Pregnant or lactating females. Serum pregnancy test to be assessed within 7 days prior to study treatment start, or within 14 days with a confirmatory urine pregnancy test within 7 days prior to study treatment start. Men and women of childbearing potential not using effective means of contraception.
  • Known other non-adenocarcinoma pathological type.
  • Other primary tumour (including primary brain tumours) within the last 5 years prior to enrollment, except for adequately treated carcinoma in situ of the cervix or basal cell skin cancer.
  • Inability to take oral medication, prior surgical procedures affecting absorption or unwilling to take the Traditional Chinese Medicine.
  • Patiens who are suffering from diarrhea.
  • Subjects with poor compliance.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

    • PRINCIPAL_INVESTIGATOR: zhen Chen, M.D., Fudan University

    Publications

    The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

    General Publications

    No publications available

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